Evryàl Soft Cross-linked Hyaluronic Acid Filler

FOR MEDICAL USE ONLY

Cross-linked hyaluronic filler Evryàl Soft 15 mg/ml

FILLER FOR THE TREATMENT OF FACIAL IMPERFECTIONS BASED ON CROSS-LINKED HYALURONIC ACID

EVRYÀL is a highly tolerable, viscoelastic, sterile filler based on cross-linked hyaluronic acid , ideal for subcutaneous applications. The action of EVRYÀL is expressed in the increase in the volume of the dermoepidermal tissue based on the natural ability of the hydroyl molecules of hyaluronic acid to attract a moderate quantity of water and bind to it. This allows the intercellular matrix to be integrated, filling the intradermal spaces, giving turgidity to the tissues. The cross-linking of the hyaluronic acid contained in the product makes the filling effect more stable and durable over time. In fact, unlike linear hyaluronic acid, EVRYÀL is slowly reabsorbed by the skin within 6-8 months, giving the treated skin a natural appearance for longer. BDDE , used as a cross-linking agent, in addition to being safe, offers efficient results while meeting market demands. EVRYÀL is an injectable, non-pyrogenic, reabsorbable medical device with CE 0373 marking, based on cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation. It comes in the form of a monophasic colorless gel contained in a pre-filled, ergonomic, disposable glass syringe with Luer connection. The syringe, equipped with a plastic support which increases its handling, has a precise graduation which allows direct control and easy reading of the volume of the injected product. The controls carried out during the entire production process and during packaging, based on the use of technologically cutting-edge methods which involve the electronic verification of all the fillers produced, ensure quality and purity, guaranteeing the safety of the product. These production standards, in addition to the very low concentration of nucleic acids and proteins and a rate of bacterial endotoxins < 0.5 EU/ml (definitely lower than the limits of the European Pharmacopoeia for injectable products), reduce any hypersensitivity reactions to a minimum.

CLINICAL STUDIES

A pre-clinical study conducted by ten specialists (dermatologists, plastic surgeons and aesthetic doctors) on 145 patients (women, average age 50 years) over a period of one year showed excellent durability of the product. Graph no. 1 shows the duration of treatment in the three different dosages. From the satisfaction questionnaires filled out by the specialists involved in the study, an average satisfaction index (ASI) of patients and doctors of 8/10 in a year is derived. The parameters taken into consideration in the questionnaire are the good malleability and tolerability of the product, the immediate effect, the pain during the treatment which was found to be non-existent or if present still bearable, the absence of edema (graph no. 2).

RESULTS

Three different doses allow you to treat all areas of the face, reducing all types of wrinkles (fine, deep) and reshaping the face and lips by deeply rehydrating the skin. The result is very natural and immediately visible, EVRYÀL generates an immediate lifting effect thanks to its intrinsic viscoelastic and hydrophilic properties, allowing you to recreate the desired volumes. EVRYÀL is injected under the skin with the aim of eliminating or in any case reducing both superficial and deep wrinkles, to increase the volume of soft tissues (lips, cheekbones, cheeks) to better outline the contours of the face (face contouring) or for reconstructive purposes (scars depressed, acne and chickenpox outcomes, facial asymmetries and atrophies, non-surgical rhinoplasty). A good, long-lasting, safe result is thus obtained, considering that reabsorption occurs gradually over 6-8 months after treatment. The treatment can be repeated safely after the effects of the filling have significantly diminished. The simplicity of use and the intrinsic safety of the product make it easier for the doctor to carry out the treatment. The doctor performs a few microinjections of the product in the areas to be treated, after careful cleansing and disinfection of the skin. The treatment is well tolerated and generally not painful.

SOFT

Treatment of periocular wrinkles. As an injection technique, we recommend linear retrograde injection, which must trace the superficial course of the wrinkle with extreme precision. Overcorrections should be avoided. To perform this technique it is necessary to stretch the skin with the fingers of the hand not holding the syringe, carefully avoiding the capillaries highlighted on the surface. After the implant it is important to massage the treated surface in order to better distribute the product under the skin.

MEDIUM

Treatment of periolar wrinkles, it is also indicated for volumizing the contour of the lips and eyebrows. The implant is carried out at the level of the superficial dermis, avoiding overcorrections. Any corrections can be made both with the sequential microponics technique and the linear retrograde one, depending on the operator's manual skills. It is advisable to massage the treated parts firmly.

STRONG

Treatment of medium-deep wrinkles on the face, volumetric increase in the cheekbones, chin, bridge of the nose and lips. Retrograde linear technique, to be preferred to that of sequential micro-ponics. It is recommended to inject the product at the deep dermis level.

Evryàl is produced in Italy by Apharm Srl

Evryàl is a CE 0373 medical device